Predictors and Intervention for Noncompliance
This is a randomized controlled intervention trial in poorly compliant patients, testing whether improved compliance behavior decreases rates of acute rejection risk and graft loss.
Hypothesis: A study of an intensive intervention focused on the least compliant patients and beginning 3 months post-transplant. Effective intervention will reduce the number of acute rejection episodes and thus the occurrence of chronic rejection and graft loss.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Predictors and Intervention for Noncompliance|
- Graft loss [ Time Frame: prospective ] [ Designated as safety issue: No ]
- Acute rejection [ Time Frame: prospective ] [ Designated as safety issue: No ]
- Death [ Time Frame: prospective ] [ Designated as safety issue: No ]
|Study Start Date:||August 1998|
|Study Completion Date:||December 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Experimental: Phone calling
Phone calling to encourage improved adherence
Behavioral: Intensive telephone followup
Our original studies demonstrated "early" noncompliant behavior predicted adverse transplantation outcomes including acute graft rejection and graft loss. In this study, we are randomly assigning a telephone intervention in a prospective cohort of medically noncompliant patients. Standard therapy includes specifically warning patients about the risks of noncompliant behavior, and the formal intervention is randomized so half of these patients will also receive intensive telephone followup, intended to improve medication compliance and reduce adverse events.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148174
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Thomas E Nevins, MD||University of Minnesota - Clinical and Translational Science Institute|